Laboratory Services for the Processing, Testing,

WESTINGHOUSE ANNISTON P.O. BOX 2000 ANNISTON, AL 36202-2000 June 14, 2011 SC-AM-11-000563 Subject: Request for Information (RFI) Sources Sought Laboratory Services for the Processing, Testing, and Monitoring for RBC Cholinesterase Attn: Prospective Sources: Westinghouse Anniston (WA) is soliciting information on the potential to perform the services described below for the Anniston Chemical Disposal Facility (ANCDF), Anniston, Alabama. This is a Sources Sought Notice only. Solicitations are not available at this time. Market research is being conducted to determine potential sources for this requirement. All information submitted in response to this notice is voluntary and WA will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to WA. Interested companies are invited to review the description of work to be performed and qualifications. Please provide comments along with capabilities. If not qualified, but capable of meeting the requirements, advise on that capability. Description of Work to be Performed - 1. REQUIREMENTS, SCOPE OF WORK AND Critical Performance StandarDS RBC Cholinesterase (ChE) Processing, Testing and Monitoring Laboratory Services for the Anniston Chemical Agent Disposal Facility (ANCDF). All significant work is located outside the Chemical Limited Area (CLA); occasional entry in the Chemical Limited area (CLA) is desirable. Provide all labor, materials, and equipment in accordance with this document. The requirements and scope of work include: Vendor must provide a CLIA/USAPHC (US Army Public Health Command) Certified Technician to perform RBC-ChE testing and Phlebotomies for RBC-ChE's, to include any CLIA, OSHA, USAPHC or regulatory requirements concerning phlebotomies and maintenance of a RBC-ChE Laboratory. Vendor's technician must be able to obtain and maintain Site Access safety and security requirements. Vendor must meet CLIA requirements for a High Complexity Lab (listed below)* Vendor must participate in and meet U.S. Army, CMA and USAPHC requirements for a RBC-ChE lab ( example, DA PAM 40-8, Implementation Guidance Policy for New Airborne Exposure Limits for GB, GA, GD, GF, VX, H, HD and HT dated June 18, 2004). Includes initial procedure set-up and ensuring update to existing procedures as new guidance is provided. Vendor must maintain electronic SF 512's, provide lab results for medical records, coordinate review of reports/analysis with ANCDF Medical Director. Vendor must establish a system of ensuring that ALL employees enrolled in the RBC-ChE monitoring program are 100% compliant in accordance with USAPHC and CMA guidelines. RBC-ChE staff must meet and maintain CLIA and USAPHC training requirements for a RBC-ChE lab. Inspections by CMA, SMR, CSI, USAPHC, CLIA and ORR teams are continuous. Vendor must have a system in place to ensure successful inspections with a plan for tracking and responding to deficiencies and observations through completion. Vendor must have Controlled Substance maintenance in accordance with Army Regulation AR 190-51. 2. CLIA Requirements for High Complexity Lab Qualification Positions Required for RBC-ChE High Complex Lab: MD- medical director MT - Medical technician MLT - medical lab technician See http://www.cdc.gov/clia/regs/toc.aspx for complete requirements under sub section M, under CFR part 793 Director MD with either one (1) year of lab training during medical residency, or at least two (2) years of experience directing or supervising high complexity testing. Technical Supervisor MD with a least 1 year of laboratory training or experience, or both, in high complexity testing, with at least six (6) months of high complexity experience within designated specialty OR MT with at least four (4) years of laboratory training or experience, or both in high complexity testing, with at least six (6) months of high complexity experience within designated specialty. Clinical Consultant MD General Supervisor MT Testing Personnel MD, MT, or MLT with an associate's degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution 3. Certification and Lab Requirements QA Program acceptable to CLIA and USAPHC. CLIA Certification for the duration of the contract. USAPHC Certification Attend required USAPHC hands-on training (as well as required on-site and CMA training) as needed. Maintain RBC-ChE lab equipment and supplies Provide controlled copies of QA/QC laboratory procedures Implement filing system for test and QA sample results Establish system of keeping up with RBC-ChE employee requirements in current OHM data base Set up calibration schedules on equipment Establish schedule for back-up laboratory technicians and/or off-site back-up coverage. Run samples and familiarize self with controls and equipment (Volume approximately 500-600 samples from Oct 1, 2011 to end of Phase 4 currently scheduled for 4th Quarter 2013. Inspections by CLIA, and USAPHC. Ship specimens to USAPHC for required QA controls Maintain Semi Annual Certification/Certificate of Compliance 4. Critical Performance Standards Positive USAPHC, CLIA, CSI, SAV SMR inspection results Positive Quarterly Proficiency Testing Results QA reports from USAPHC submittals 5. Schedule RBC-ChE baseline and termination determinations may be batched and processed on a weekly basis. 6. Referenced Guidence Interim Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Nerve Agents GA, GB, GD, GF, and VX - Revised 8 June 2004. DA Pamphlet (PAM) 40-8 Technical Bulletin MED 590 All responses shall be submitted via e-mail to contact@example.gov or mailed to Westinghouse Anniston, P.O. Box 2000; Anniston, AL 36202 Attn: Alan McDermott, Subcontract Administrator.